AMINOSOL 5%
Clinical safety rating
cautionComprehensive clinical and safety monograph for AMINOSOL 5% (AMINOSOL 5%).
Aminosyl 5% is a parenteral amino acid solution that provides essential and non-essential amino acids for protein synthesis, tissue repair, and maintenance of nitrogen balance in patients unable to tolerate enteral feeding.
| Metabolism | Amino acids are metabolized primarily in the liver via transamination, deamination, and urea cycle. Excretion of nitrogenous waste as urea occurs renally. |
| Excretion | Excretion of infused amino acids is primarily renal, with small amounts lost via feces and skin. Approximately 85-95% of the nitrogen load is excreted in urine as urea, ammonia, and other nitrogenous wastes. Less than 5% is eliminated in feces. |
| Half-life | The half-life of infused amino acids is not defined as they are endogenous compounds. However, the nitrogen from amino acids has a biological half-life of approximately 6-18 hours, depending on metabolic activity. As part of total parenteral nutrition, the elimination half-life of infused amino acids is influenced by protein turnover and catabolism. |
| Protein binding | Amino acids are not protein-bound; they exist free in plasma. Minimal reversible binding to albumin occurs for some amino acids, but overall binding is <10%. |
| Volume of Distribution | The volume of distribution for amino acids is approximately 0.3-0.4 L/kg, reflecting distribution primarily in extracellular fluid and to a lesser extent intracellularly. |
| Bioavailability | Intravenous: 100% bioavailability. Not administered via other routes; oral or enteral administration is not applicable due to hepatic first-pass metabolism and different pharmacokinetics. |
| Onset of Action | Intravenous infusion: Immediate pharmacological effects as amino acids become available for protein synthesis and metabolic processes within minutes of initiation. |
| Duration of Action | Duration depends on infusion rate and metabolic demand. Continuous infusion maintains sustained nitrogen balance; effects persist throughout infusion and for several hours post-infusion as amino acids are metabolized. |
| Molecular Weight | AminoSol 5% is a mixture of amino acids; individual molecular weights range from 75 (glycine) to 204 (tryptophan) Da. |
Intravenous infusion: 500 mL to 1 L of 5% solution over 8-12 hours, providing 25-50 g of amino acids. Maximum infusion rate: 0.1 g/kg/hour. Dose based on metabolic requirements and clinical status.
| Dosage form | INJECTABLE |
| Renal impairment | In GFR < 50 mL/min: reduce infusion rate by 50% and monitor nitrogen balance. In ESRD on dialysis: use only if essential; typical dose 0.5-0.6 g/kg/day of amino acids with careful monitoring. |
| Liver impairment | Contraindicated in severe hepatic failure (Child-Pugh C) due to risk of hepatic encephalopathy. In Child-Pugh A or B, use with caution and reduce dose by 30-50%; monitor ammonia levels. |
| Pediatric use | Infants and children: 1-2 g/kg/day of amino acids via total parenteral nutrition (TPN) as a 5% solution. Adjust based on age, weight, and clinical condition. Maximum infusion rate 0.1 g/kg/hour. |
| Geriatric use | Start at lower end of dosing; monitor renal function (creatinine clearance) and avoid fluid overload. Typical initial dose: 0.8-1 g/kg/day of amino acids, adjusted to tolerance and clinical response. |
| 1st trimester | Amino acids are essential for fetal development; however, use only if clearly needed and monitor for maternal metabolic disturbances. |
| 2nd trimester | Generally considered safe when maternal nutritional status is compromised; monitor for fluid and electrolyte imbalances. |
| 3rd trimester | Safe when used for maternal indications; avoid hyperammonemia or metabolic acidosis, which may affect the fetus. |
Clinical note
Comprehensive clinical and safety monograph for AMINOSOL 5% (AMINOSOL 5%).
| Placental transfer | Amino acids cross the placenta by active transport; specific data for AminoSol 5% not available, but physiological transfer occurs. |
| Breastfeeding | AminoSol 5% is a source of amino acids; it is unlikely to cause adverse effects in the infant. However, maternal nutritional status should be monitored, and intravenous administration may affect milk composition. |
| Lactation Rating | L2 |
| Teratogenic Risk | Aminosol 5% is a crystalline amino acid solution used for parenteral nutrition. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with Aminosol 5%. Therefore, the teratogenic risk is not well defined. However, as a component of parenteral nutrition, it is considered essential for maternal and fetal health when indicated. Use only if clearly needed, weighing potential benefits against unknown risks. No specific trimester-associated risks have been reported. |
| Fetal Monitoring | Monitor maternal fluid and electrolyte balance, acid-base status, serum ammonia, liver function tests, renal function (BUN, creatinine), and blood glucose levels. In the fetus, monitor growth parameters and well-being via ultrasound if prolonged use. Monitor for signs of fluid overload or metabolic imbalances. |
| Fertility Effects | No specific studies have evaluated effects on fertility. As an amino acid solution used for nutritional support, it is not expected to adversely affect fertility. However, underlying conditions requiring parenteral nutrition may impact fertility. |
■ FDA Black Box Warning
None.
| Serious Effects |
Severe metabolic acidosisHyperammonemiaInborn errors of amino acid metabolismSevere hepatic insufficiencySevere uremia without dialysis
| Precautions | Use with caution in patients with renal impairment (risk of azotemia and electrolyte imbalances), Monitor serum electrolytes, blood glucose, and fluid balance regularly, Risk of hyperglycemia in diabetic patients; adjust insulin accordingly, Possible hyperammonemia, especially in patients with hepatic insufficiency, Contains aluminum; may accumulate in renal impairment, leading to osteomalacia or neurotoxicity |
| Food/Dietary | No direct food interactions as Aminos 5% is administered intravenously. However, oral dietary intake must be coordinated with total parenteral nutrition to avoid excessive protein or electrolyte intake. |
| Clinical Pearls | Aminos 5% is a crystalline amino acid solution used for parenteral nutrition. In renal failure, adjust dose to limit nitrogen load; monitor BUN. In hepatic encephalopathy, consider branched-chain amino acid formulations. Do not administer concurrently with blood products through same IV line due to risk of agglutination. Infuse via central line if peripheral veins insufficient; peripheral administration requires adequate lipid-based calorie co-administration to prevent phlebitis. |
| Patient Advice | This solution provides essential building blocks (amino acids) for protein synthesis when you cannot eat. · Report any signs of infection at the IV site: redness, swelling, pain, or drainage. · Tell your doctor if you experience nausea, vomiting, or headache; dose adjustment may be needed. · Do not abruptly stop this infusion; it is part of your total nutrition plan. · Regular blood tests will be required to monitor kidney and liver function. |
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